Company Announcement
- Phase 3 APOLLO randomized study evaluating subcutaneous
daratumumab in combination with pomalidomide and dexamethasone
versus pomalidomide and dexamethasone alone in relapsed or
refractory multiple myeloma met the primary endpoint of improving
progression-free survival
- Janssen intends to discuss the data with health
authorities for potential regulatory submissions
Copenhagen, Denmark; July 31, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that the European
Myeloma Network (EMN) in collaboration with Janssen Research &
Development, LLC (Janssen) reported positive
results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous
(SC) formulation of daratumumab in combination with pomalidomide
and dexamethasone (Pd) versus Pd alone as treatment for patients
with relapsed or refractory multiple myeloma who have previously
been treated with lenalidomide (an immunomodulatory drug) and a
proteasome inhibitor (PI). The study met the primary
endpoint of improving progression-free survival (PFS). Overall, the
safety profile of daratumumab SC in combination with Pd was
consistent with the safety profile for each therapy separately.
“We are pleased with these positive results for daratumumab,
administered as a subcutaneous formulation, in combination with
pomalidomide and dexamethasone. The corresponding intravenous
regimen was previously approved by the U.S. FDA based on the Phase1
single-arm EQUULEUS study,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.
Janssen Biotech, Inc., which obtained an exclusive worldwide
license to develop, manufacture and commercialize daratumumab from
Genmab in 2012, intends to discuss the data with health authorities
in preparation for regulatory submissions and plans to submit the
data for presentation at an upcoming medical conference.
The APOLLO study was designed to confirm the results from the
Phase 1 EQUULEUS (MMY1001) study, which investigated intravenous
(IV) daratumumab plus Pd in the same indication. In June 2017, the
U.S. Food and Drug Administration (U.S. FDA) approved the use of
DARZALEX in combination with Pd for the treatment of patients with
multiple myeloma who have received at least two prior therapies
including lenalidomide and a PI based on the results of the
EQUULEUS study.
About the APOLLO (MMY3013) studyThis Phase 3
(NCT03180736), randomized, open-label, multicenter study included
304 patients with multiple myeloma who have previously been treated
with lenalidomide and a PI. Patients were randomized 1:1 to either
receive daratumumab in combination with Pd or Pd alone. In the
original design of the study, patients in the daratumumab plus Pd
arm were treated with the IV formulation of daratumumab. As of
Amendment 1, all new subjects in the experimental arm were dosed
with the SC formulation of daratumumab and patients who had already
begun treatment with IV daratumumab had the option to switch to the
SC formulation. The primary endpoint of the study was PFS. The
study was conducted in Europe under an agreement between Janssen,
EMN and Stichting Hemato-Oncologie voor Volwassenen Nederland
(HOVON).
About multiple myelomaMultiple myeloma is an
incurable blood cancer that starts in the bone marrow and is
characterized by an excess proliferation of plasma cells.1 Multiple
myeloma is the third most common blood cancer in the U.S., after
leukemia and lymphoma.2 Approximately 26,000 new patients were
estimated diagnosed with multiple myeloma and approximately 13,650
people were expected to have died from the disease in the U.S. in
2018.3 Globally, it was estimated that 160,000 people were
diagnosed and 106,000 died from the disease in 2018.4 While
some patients with multiple myeloma have no symptoms at all, most
patients are diagnosed due to symptoms which can include bone
problems, low blood counts, calcium elevation, kidney problems or
infections.5
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) intravenous
infusion is indicated for the treatment of adult patients in the
United States: in combination with bortezomib, thalidomide and
dexamethasone as treatment for patients newly diagnosed with
multiple myeloma who are eligible for autologous stem cell
transplant; in combination with lenalidomide and dexamethasone for
the treatment of patients with newly diagnosed multiple myeloma who
are ineligible for autologous stem cell transplant; in combination
with bortezomib, melphalan and prednisone for the treatment of
patients with newly diagnosed multiple myeloma who are ineligible
for autologous stem cell transplant; in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone,
for the treatment of patients with multiple myeloma who have
received at least one prior therapy; in combination with
pomalidomide and dexamethasone for the treatment of patients with
multiple myeloma who have received at least two prior therapies,
including lenalidomide and a proteasome inhibitor (PI); and as a
monotherapy for the treatment of patients with multiple myeloma who
have received at least three prior lines of therapy, including a PI
and an immunomodulatory agent, or who are double-refractory to a PI
and an immunomodulatory agent.6 DARZALEX is the first monoclonal
antibody (mAb) to receive U.S. Food and Drug Administration (U.S.
FDA) approval to treat multiple myeloma.
DARZALEX is indicated for the treatment of adult patients in
Europe via intravenous infusion or subcutaneous administration: in
combination with bortezomib, thalidomide and dexamethasone as
treatment for patients newly diagnosed with multiple myeloma who
are eligible for autologous stem cell transplant; in combination
with lenalidomide and dexamethasone for the treatment of patients
with newly diagnosed multiple myeloma who are ineligible for
autologous stem cell transplant; in combination with bortezomib,
melphalan and prednisone for the treatment of adult patients with
newly diagnosed multiple myeloma who are ineligible for autologous
stem cell transplant; for use in combination with lenalidomide and
dexamethasone, or bortezomib and dexamethasone, for the treatment
of adult patients with multiple myeloma who have received at least
one prior therapy; and as monotherapy for the treatment of adult
patients with relapsed and refractory multiple myeloma, whose prior
therapy included a PI and an immunomodulatory agent and who have
demonstrated disease progression on the last therapy7. Daratumumab
is the first subcutaneous CD38-directed antibody approved in Europe
for the treatment of multiple myeloma. The option to split the
first infusion of DARZALEX over two consecutive days has been
approved in both Europe and the U.S.
In Japan, DARZALEX intravenous infusion is approved for the
treatment of adult patients: in combination with lenalidomide and
dexamethasone for the treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell
transplant; in combination with bortezomib, melphalan and
prednisone for the treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell
transplant; in combination with lenalidomide and dexamethasone, or
bortezomib and dexamethasone for the treatment of relapsed or
refractory multiple myeloma. DARZALEX is the first human CD38
monoclonal antibody to reach the market in the United States,
Europe and Japan. For more information, visit www.DARZALEX.com.
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a
subcutaneous formulation of daratumumab, is approved in the United
States for the treatment of adult patients with multiple myeloma:
in combination with bortezomib, melphalan and prednisone in newly
diagnosed patients who are ineligible for ASCT; in combination with
lenalidomide and dexamethasone in newly diagnosed patients who are
ineligible for ASCT and in patients with relapsed or refractory
multiple myeloma who have received at least one prior therapy; in
combination with bortezomib and dexamethasone in patients who have
received at least one prior therapy; and as monotherapy, in
patients who have received at least three prior lines of therapy
including a PI and an immunomodulatory agent or who are
double-refractory to a PI and an immunomodulatory agent.8 DARZALEX
FASPRO is the first subcutaneous CD38-directed antibody approved in
the U.S. for the treatment of multiple myeloma.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that
binds with high affinity to the CD38 molecule, which is highly
expressed on the surface of multiple myeloma cells. Daratumumab
triggers a person’s own immune system to attack the cancer cells,
resulting in rapid tumor cell death through multiple
immune-mediated mechanisms of action and through immunomodulatory
effects, in addition to direct tumor cell death, via apoptosis
(programmed cell death).6,9,10,11,12
Daratumumab is being developed by Janssen Biotech, Inc. under an
exclusive worldwide license to develop, manufacture and
commercialize daratumumab from Genmab. A comprehensive clinical
development program for daratumumab is ongoing, including multiple
Phase III studies in smoldering, relapsed and refractory and
frontline multiple myeloma settings. Additional studies are ongoing
or planned to assess the potential of daratumumab in other
malignant and pre-malignant diseases in which CD38 is expressed,
such as amyloidosis and T-cell acute lymphocytic leukemia (ALL).
Daratumumab has received two Breakthrough Therapy Designations from
the U.S. FDA for certain indications of multiple myeloma, including
as a monotherapy for heavily pretreated multiple myeloma and in
combination with certain other therapies for second-line treatment
of multiple myeloma.
About Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company is the creator of
three approved antibodies: DARZALEX® (daratumumab, under agreement
with Janssen Biotech, Inc.) for the treatment of certain multiple
myeloma indications in territories including the U.S., Europe and
Japan, Arzerra® (ofatumumab, under agreement with Novartis AG), for
the treatment of certain chronic lymphocytic leukemia indications
in the U.S., Japan and certain other territories and TEPEZZA®
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, known as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S.,
has been approved in the U.S. and Europe for the treatment of adult
patients with certain multiple myeloma indications. Daratumumab is
in clinical development by Janssen for the treatment of additional
multiple myeloma indications, other blood cancers and amyloidosis.
A subcutaneous formulation of ofatumumab is in development by
Novartis for the treatment of relapsing multiple sclerosis. Genmab
also has a broad clinical and pre-clinical product pipeline.
Genmab's technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody® platform for
generation of bispecific antibodies, the HexaBody® platform, which
creates effector function enhanced antibodies, the HexElect®
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency and the DuoHexaBody® platform, which enhances the potential
potency of bispecific antibodies through hexamerization. The
company intends to leverage these technologies to create
opportunities for full or co-ownership of future products. Genmab
has alliances with top tier pharmaceutical and biotechnology
companies. Genmab is headquartered in Copenhagen, Denmark with
sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
Tokyo, Japan.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
This Company Announcement contains forward looking statements. The
words “believe”, “expect”, “anticipate”, “intend” and “plan” and
similar expressions identify forward looking statements. Actual
results or performance may differ materially from any future
results or performance expressed or implied by such statements. The
important factors that could cause our actual results or
performance to differ materially include, among others, risks
associated with pre-clinical and clinical development of products,
uncertainties related to the outcome and conduct of clinical trials
including unforeseen safety issues, uncertainties related to
product manufacturing, the lack of market acceptance of our
products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and
proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our
products or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Company
Announcement nor to confirm such statements to reflect subsequent
events or circumstances after the date made or in relation to
actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks:
Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the
Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination
with the DuoBody logo®; HexaBody®; HexaBody in combination with the
HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is
a trademark of Novartis AG or its affiliates. DARZALEX® and
DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV.
TEPEZZA® is a trademark of Horizon Therapeutics plc.
1 American Cancer Society. "Multiple Myeloma Overview."
Available at
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed
June 2016.2 National Cancer Institute. "A Snapshot of Myeloma."
Available at www.cancer.gov/research/progress/snapshots/myeloma.
Accessed June 2016. 3 Globocan 2018. United States of America Fact
Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4
Globocan 2018. World Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed December 2018.5 American Cancer Society. "How is Multiple
Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis.
Accessed June 20166 DARZALEX Prescribing information, September
2019. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf
Last accessed September 20197 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed June 20208 DARZALEX FASPRO Prescribing information, May
2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel
Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of
Multiple Myeloma and Other Hematological Tumors. The Journal of
Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al.
Antibody-mediated phagocytosis contributes to the anti-tumor
activity of the therapeutic antibody daratumumab in lymphoma and
multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al.
Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell
Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood.
2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human
CD38 antibody induces apoptosis of myeloma tumor cells via Fc
receptor-mediated crosslinking. Blood. 2012; 120(21): abstract
2974.
Company Announcement no. 33CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
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